Completed

Safety, Tolerance and Efficacy of SCH 56592 versus Fluconazole in Treating Oropharyngeal Candidiasis in HIV-Positive Patients

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Posaconazole

+ Fluconazole

Drug
Who is being recruted

Blood-Borne Infections+19

+ Urogenital Diseases

+ Genital Diseases

From 18 to 65 Years
+29 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
See protocol details

Summary

Principal SponsorSchering-Plough
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

This is a randomized, multicenter, double-blind study consisting of 5 arms (4 dose levels of SCH 56592 vs fluconazole) in the treatment of oropharyngeal candidiasis (OPC) in HIV-positive patients.

NCT00002399
Principal SponsorSchering-Plough
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

500 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesBacterial Infections and MycosesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsStomatognathic DiseasesMouth DiseasesMycosesOpportunistic InfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsCandidiasisCandidiasis, OralHIV InfectionsAIDS-Related Opportunistic Infections

Criteria

4 inclusion criteria required to participate
Ability to swallow study medication
Documented HIV seropositivity (by Western blot or other approved confirmatory test) prior to enrollment
Fungal stain or KOH consistent with Candida species, confirmed by a positive mycologic culture
Pseudomembranous oropharyngeal candidiasis
25 exclusion criteria prevent from participating
All forms of OPC other than pseudomembranous (unless accompanied by pseudomembranous OPC)
Astemizole within 10 days prior to enrollment
Current known drug abuse, in the opinion of the lead investigator, that would interfere with the subject's participation in the study
Cytokines (except erythropoietin), interferon, or lymphocyte replacement therapy unless patient already taking these agents for at least 30 days prior to enrollment
Show More Criteria

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 53 locations

Tucson Veterans Administration Med Ctr

Tucson, United StatesOpen Tucson Veterans Administration Med Ctr in Google Maps

Northeast Arkansas Clinic

Jonesboro, United States

Miami Veterans Administration Med Ctr

Miami, United States

Mercy Hosp

Miami, United States
Completed53 Study Centers